Technology-Supported Treatment of Sleep Apnea in Prediabetes

糖尿病前期睡眠呼吸暂停的技术支持治疗

• 批准号: 9762470
• 负责人: Esra Tasali
• 金额: $ 73.74万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9762470
• 关键词: Address; Adherence; Advisory Committees; Beta Cell; Blood Pressure; Body Weight decreased; Cardiovascular Diseases; Cardiovascular Physiology; Cardiovascular system; Caring; Cell physiology; Clinical; Clinical Trials; Continuous Positive Airway Pressure; Diabetes Mellitus; Diagnosis; Diastolic blood pressure; Diet; Disease; Environment; Fasting; Feedback; General Population; Glucose; Goals; Health; High Density Lipoprotein Cholesterol; High Prevalence; Hour; Incidence; Individual; Intervention; Knowledge; LDL Cholesterol Lipoproteins; Laboratories; Level of Evidence; Life; Life Style; Life Style Modification; Link; Lipids; Metabolic; Methods; Modeling; Monitor; OGTT; Obesity; Obstructive Sleep Apnea; Outcome; Overweight; Patients; Prediabetes syndrome; Preventive Health Services; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Sampling; Sleep Apnea Syndromes; Specialist; Technology; Testing; Time; Triglycerides; Weight; Work; adult obesity; behavior change; blood lipid; cardiometabolic risk; cardiometabolism; clinical decision-making; clinically relevant; cost effective; diet and exercise; evidence base; glucose metabolism; high risk; high risk population; improved; insulin sensitivity; lifestyle intervention; novel; prevent; primary outcome; routine screening; screening; smartphone Application; standard of care; success; treatment adherence

PROJECT SUMMARY Intensive lifestyle interventions (diet and exercise) are the mainstay of treatment in prediabetes. Despite their efficacy, diabetes incidence is rising, and thus there is a critical need for additional strategies to prevent diabetes and to reduce its cardiovascular complications. Sleep apnea is a treatable disorder that has been strongly associated with cardiometabolic disease. Continuous positive airway pressure (CPAP) is the recommended treatment for those who are diagnosed with sleep apnea. However, about 80% of patients who have sleep apnea remain undiagnosed, and thus not receive CPAP treatment. To date, not a single clinical trial investigating the effects of lifestyle interventions on cardiometabolic risk in prediabetes assessed for sleep apnea or included an intervention to treat sleep apnea. Despite high prevalence of sleep apnea in prediabetes, the vast majority of patients are not diagnosed due to lack of high level evidence to indicate that treatment specifically improves diabetes and cardiovascular outcomes, which are the primary treatment objectives of specialists caring for this high-risk population. Moreover, due to insufficient evidence from rigorous and well-powered randomized controlled trials, the U.S. Preventive Health Services Task Force recommended against general screening for sleep apnea. Notably, not a single randomized controlled CPAP trial assessing cardiometabolic outcomes utilized a technology-supported intervention to promote adherence, a key limitation in prior studies. Our proposed randomized clinical trial will fill these critical knowledge gaps and address a focused, novel and clinically relevant question. We will determine, for the first time, whether adding CPAP treatment to a lifestyle intervention improves cardiometabolic outcomes beyond that achieved with lifestyle alone (i.e. current standard of care) in prediabetes. Overweight and obese adults who have prediabetes and sleep apnea will be randomly assigned to lifestyle alone or lifestyle plus CPAP. We will obtain the same metabolic and cardiovascular assessments at baseline and after 6-months of intervention. Our specific aims are to test the hypothesis that a combined intervention (lifestyle plus CPAP) will lead to greater improvements in glucose levels, insulin sensitivity and beta cell function (Aim 1), and blood pressure and lipid profile (Aim2), as compared to lifestyle alone. To maximize intervention success and minimize subject burden, we propose a highly efficient, cost effective technology-supported approach for lifestyle intervention and CPAP treatment, which will allow real-time, objective monitoring of individuals in their habitual environment and delivering timely feedback to attain goals. To date, no prior study has implemented such a technology-supported intervention in people with prediabetes and sleep apnea. An added benefit of CPAP on cardiometabolic outcomes will strongly support routine screening for and treatment of sleep apnea in prediabetes and will encourage those prescribing CPAP to routinely implement intensive lifestyle modifications as part of treatment package for sleep apnea. Our trial will address a major gap in randomized clinical trials on the impact of sleep apnea treatment on glucose metabolism, and thus inform evidence-based clinical decision making.

项目总结 强化的生活方式干预(饮食和运动)是治疗糖尿病前期疾病的主要手段。尽管他们 由于糖尿病的有效性，糖尿病发病率正在上升，因此迫切需要采取额外的策略来预防糖尿病 并减少其心血管并发症。睡眠呼吸暂停是一种可治疗的疾病，一直以来 与心脏代谢性疾病有关。推荐使用持续气道正压通气(CPAP) 对那些被诊断为睡眠呼吸暂停的人进行治疗。然而，大约80%患有睡眠呼吸暂停的患者 仍未确诊，因此未接受CPAP治疗。到目前为止，还没有一项临床试验调查 生活方式干预对糖尿病前期患者心脏代谢风险的影响评估睡眠呼吸暂停或纳入 干预治疗睡眠呼吸暂停。尽管糖尿病前期的睡眠呼吸暂停发生率很高，但绝大多数 由于缺乏高水平的证据表明治疗有特别的改善，患者没有得到诊断 糖尿病和心血管结果，这是护理这一疾病的专家的主要治疗目标 高危人群。此外，由于严谨而有力的随机调查证据不足， 对照试验，美国预防卫生服务工作组建议不要进行全面筛查 睡眠呼吸暂停。值得注意的是，没有一项评估心脏代谢结果的随机对照CPAP试验 利用技术支持的干预措施来促进依从性，这是以前研究中的一个关键限制。我们的建议 随机临床试验将填补这些关键知识空白，并解决有重点的、新颖的和临床相关的 问题。我们将首次确定，在生活方式干预中加入CPAP治疗是否会有所改善 糖尿病前期患者的心脏代谢结果超出了仅靠生活方式(即目前的护理标准)取得的结果。 有糖尿病前期和睡眠呼吸暂停的超重和肥胖成年人将被随机分配到单独的生活方式 或者生活方式加上CPAP。我们将在基线和之后获得相同的代谢和心血管评估 6个月的干预。我们的具体目标是检验一种联合干预(生活方式+ CPAP)将导致血糖水平、胰岛素敏感性和β细胞功能的更大改善(目标1)，以及 血压和血脂谱(AIM2)，与单独的生活方式相比。为了最大限度地提高干预成功率和 将主体负担降至最低，我们提出了一种高效、成本效益高的技术支持的生活方式 干预和CPAP治疗，这将允许实时、客观地监测个人的习惯 环境和提供及时的反馈以实现目标。到目前为止，还没有任何先前的研究实现了这样的 对糖尿病前期和睡眠呼吸暂停患者进行技术支持的干预。CPAP的另一个好处是 心脏代谢结果将有力地支持糖尿病前期睡眠呼吸暂停的常规筛查和治疗 并将鼓励开CPAP处方的人例行公事地实施密集的生活方式改变，作为 睡眠呼吸暂停治疗包。我们的试验将解决有关影响的随机临床试验中的一个主要空白。 研究睡眠呼吸暂停治疗对糖代谢的影响，从而为循证临床决策提供参考。